Muscle WastingSPRINTNCT07062562
The Effect of Repeated Whole-body NMES Sessions With or Without Protein Intake on Muscle Protein Synthesis During 3 Days of Bed Rest in Healthy Young Volunteers
A study testing NMES, Protein bolus (20g) and Standard nutrition in people with Muscle Wasting, run by Wageningen University at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to examine the effect of whole-body electrostimulation with protein intake on muscle protein synthesis, muscle mass and function during bed rest in healthy young adults (18-35 years). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Wasting
- What is being tested?
- NMES, Protein bolus (20g) and Standard nutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 May 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged from 18-35 years
- 18.5 < BMI < 30 kg·m2
- Recreationally active (performing non-competitive physical exercise at least one time per week for minimally 30 minutes)
Who cannot join
- Employed or undertaking a thesis or internship at the department of Human and Animal Physiology at Wageningen University
- Smoking
- Diabetes (Type 1, Type 2, or genetic form of diabetes)
- Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or
- ≥90 mmHg diastolic)
- Chronic use of any prescribed or over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices)
Show all 21Show fewer
- Known allergy to lidocaine
- Prone to keloid forming (i.e. hyperplastic growth of scars)
- All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g.
- arthritis, spasticity/rigidity, all neurological disorders and paralysis)
- Regular use of dietary protein and/or amino acid supplements (>3 times per week)
- Currently involved in a structured progressive resistance training programme (>3 times per week)
- A personal or family history of thrombosis (clots), epilepsy, seizures, or schizophrenia
- Any previous motor disorders or disorders in muscle and/or lipid metabolism
- Any back, leg, knee, neck, shoulder or postural complaints
- Presence of an ulcer in the stomach or gut and/or strong history of indigestion
- Contra-indications for DXA scans (e.g. undergoing radiologic examination)
- Lactose intolerance
- Known severe kidney problems
- Pregnant or breastfeeding
- Unable to give consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Wageningen University
Wageningen, Gelderland, 6708WD
Marlou Dirks, PhD, +31 317 480 100, marlou.dirks@wur.nl
Marlou Dirks, PhD
About this study
Official title: The Effect of Repeated Sessions of Whole-body Neuromuscular Electrical Stimulation (NMES), With or Without Subsequent Intake of a Protein Bolus, on Muscle Protein Synthesis in Healthy, Young Volunteers During 3 Days of Bed Rest
The goal of this clinical trial is to examine the effect of whole-body electrostimulation with protein intake on muscle protein synthesis, muscle mass and function during bed rest in healthy young adults (18-35 years). The main questions to answer are:
- Does whole-body NMES followed by protein intake improve muscle protein synthesis rates during 3 days of bed rest?
- Does repeated NMES sessions offer protective effects on muscle mass and function during extended periods of inactivity?
Read more
Researchers will compare sham electrical electrostimulation, electrical stimulation and electrical stimulation + protein groups to see if whole-body electrostimulation combined with protein intake offers the greatest improvement in muscle protein metabolism and muscle preservation.
Participants will:
- Undergo 3 days of bed rest while receiving one of the following interventions:
- Sham-NMES followed by standard nutrition (CON)
- Whole-body NMES followed by standard nutrition(NMES)
- Whole-body NMES followed by a bolus of 20g protein (NMES+PRO)
- Receive heavy water (D2O) to assess body water turnover.
- Undergo leg extension exercises to assess muscle function.
- Have quadriceps muscle thickness measured via ultrasound.
- Provide saliva samples for analysis.
- Have calf circumference measured to monitor changes in muscle mass.
Read the detailed description
Patients admitted to the hospital often experience prolonged bed rest, which can lead to rapid muscle loss and weakness. In the intensive care unit (ICU), this condition, known as ICU-acquired weakness (ICU-AW), affects up to 50% of patients and can lead to longer mechanical ventilation times, increased morbidity, and a reduced quality of life after hospital discharge. One of the key reasons for muscle loss during bed rest is an impaired response to dietary protein, which normally helps maintain muscle mass.
Neuromuscular electrical stimulation (NMES) is a method that uses small electrical currents to stimulate muscle contractions, potentially counteracting muscle loss during periods of inactivity. Previous research has shown that NMES applied to the quadriceps muscles can reduce muscle loss in sedated patients and improve muscle protein synthesis in individuals with type 2 diabetes. However, the effects of whole-body NMES in combination with timed protein intake on muscle protein metabolism during bed rest are still unknown.
This study aims to investigate the impact of both a single session and repeated sessions of whole-body NMES, with or without subsequent protein intake, on muscle protein synthesis rates, muscle mass, and function during 3 days of bed rest in healthy young adults.
Study Design:
This is a randomized, placebo-controlled clinical trial with three parallel groups. Participants will be randomly assigned to one of the following groups:
- Control Group (CON): Sham-NMES + standard nutrition
- NMES Group (NMES): Whole-body NMES + standard nutrition
- NMES + Protein Group (NMES+PRO): Whole-body NMES + 20g protein bolus
Study Procedures:
Participants will be healthy adults (18-35 years, male and female) and will undergo the following procedures:
- 3 days of strict bed rest to simulate hospitalization-related muscle disuse
- Neuromuscular electrical stimulation (NMES) sessions to assess its effect on muscle metabolism
- Muscle biopsies to measure changes in muscle protein synthesis at the molecular level
- Consumption of deuterium oxide (D₂O or "heavy water") to track muscle protein turnover
- Multiple blood and saliva samples to analyze protein metabolism markers
- Leg extension tests to assess changes in muscle function
- Quadriceps muscle thickness measurements via ultrasound
- Calf circumference measurements to assess muscle mass changes
This study will provide critical insights into how NMES and protein intake can help counteract muscle loss and weakness during hospitalization and may contribute to the development of more effective rehabilitation strategies for ICU and bedridden patients.
- Conditions
- Muscle Wasting
- Being tested
- Sham (No Treatment), NMES, Protein bolus (20g), Standard nutrition
- Keywords
- NMES, Skeletal Muscle Metabolism, Protein, Disuse
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham (No Treatment)Other
A placebo treatment in which no actual electrical stimulation is delivered, serving as a control for the active NMES.
NMESOther
Active neuromuscular electrical stimulation applied to the entire body to induce muscle contractions through small electric currents.
Protein bolus (20g)Dietary supplement
A bolus dose of 20 grams of protein provided after the NMES intervention to assess the combined effect of muscle stimulation and protein intake on muscle protein metabolism.
Standard nutritionOther
Provision of a normal Western standardized diet.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Sham-NMES with standard nutrition Receives: Other: Sham (No Treatment); Other: Standard nutrition |
| Whole-body NMES group | Active comparator | Whole-body NMES stimulation with standard nutrition Receives: Other: NMES; Other: Standard nutrition |
| Whole-body NMES + protein group | Active comparator | Whole-body NMES with a 20g protein bolus on top of the standard nutrition Receives: Other: NMES; Dietary Supplement: Protein bolus (20g); Other: Standard nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative myofibrillar fractional synthesis rate
A measure of muscle protein synthesis between two given time points.
Measured: Habitual MPS (Day -2 to Day 0), Acute effect of NMES (+protein bolus) (0 hours to 5 hours on Day 0), Bedrest MPS (Day 0 to Day 3),
Secondary outcomes (7)
Quadriceps Muscle Layer Thickness
Assessed using ultrasound, this measures changes in muscle size, indicating muscle loss or preservation during bed rest and NMES intervention.
Measured: Between Day -21 and Day -5, Day 0, Day 3, Day 6, Week 6
Body Composition
Evaluates muscle mass to determine overall changes.
Measured: Day 0 and Day 3.
Body composition
Evaluates fat distribution to determine overall changes.
Measured: Time Frame: Day 0 and Day 3.
Quadriceps Muscle Function
Assessed via a leg dynamometer.
Measured: Between Day -21 and Day -5, Day 0, Day 3, Day 6, Week 6
Quadriceps Muscle Strength
Assessed via a leg dynamometer.
Measured: Between Day -21 and Day -5, Day 0, Day 3, Day 6, Week 6
Handgrip Strength
Assessed via a hand dynamometer.
Measured: Between Day -21 and Day -5, Day 0, Day 3, Day 6, Week 6
Whole-Body Nitrogen Balance
The balance between nitrogen intake (from dietary protein) and nitrogen loss (through urine and other excretions)
Measured: Day 0 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start22 May 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized, placebo-controlled intervention trial with three parallel groups. Participants will undergo 3 days of bed rest and receive either sham-NMES, whole-body NMES, or whole-body NMES with protein to assess the effects on muscle protein synthesis. The study will measure muscle protein metabolism, strength, and function to determine whether NMES and protein intake can mitigate muscle loss during immobilization.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlou Dirks, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062562
- Sponsor's protocol ID
- NL88628.028.24
- Acronym
- SPRINT
- Status last verified
- Jul 2025
- First submitted
- 22 May 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Repeated Sessions of Whole-body Neuromuscular Electrical Stimulation (NMES), With or Without Subsequent Intake of a Protein Bolus, on Muscle Protein Synthesis in Healthy, Young Volunteers During 3 Days of Bed Rest
- ClinicalTrials.gov ID
- NCT07062562
- Acronym / sponsor ID
- SPRINT / NL88628.028.24
- Conditions
- Muscle Wasting
- Keywords
- NMES, Skeletal Muscle Metabolism, Protein, Disuse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to examine the effect of whole-body electrostimulation with protein intake on muscle protein synthesis, muscle mass and function during bed rest in healthy young adults (18-35 years). The main questions to answer are:
- Does whole-body NMES followed by protein intake improve muscle protein synthesis rates during 3 days of bed rest?
- Does repeated NMES sessions offer protective effects on muscle mass and function during extended periods of inactivity?
Researchers will compare sham electrical electrostimulation, electrical stimulation and electrical stimulation + protein groups to see if whole-body electrostimulation combined with protein intake offers the greatest improvement in muscle protein metabolism and muscle preservation.
Participants will:
- Undergo 3 days of bed rest while receiving one of the following interventions:
- Sham-NMES followed by standard nutrition (CON)
- Whole-body NMES followed by standard nutrition(NMES)
- Whole-body NMES followed by a bolus of 20g protein (NMES+PRO)
- Receive heavy water (D2O) to assess body water turnover.
- Undergo leg extension exercises to assess muscle function.
- Have quadriceps muscle thickness measured via ultrasound.
- Provide saliva samples for analysis.
- Have calf circumference measured to monitor changes in muscle mass.
Detailed description
Patients admitted to the hospital often experience prolonged bed rest, which can lead to rapid muscle loss and weakness. In the intensive care unit (ICU), this condition, known as ICU-acquired weakness (ICU-AW), affects up to 50% of patients and can lead to longer mechanical ventilation times, increased morbidity, and a reduced quality of life after hospital discharge. One of the key reasons for muscle loss during bed rest is an impaired response to dietary protein, which normally helps maintain muscle mass.
Neuromuscular electrical stimulation (NMES) is a method that uses small electrical currents to stimulate muscle contractions, potentially counteracting muscle loss during periods of inactivity. Previous research has shown that NMES applied to the quadriceps muscles can reduce muscle loss in sedated patients and improve muscle protein synthesis in individuals with type 2 diabetes. However, the effects of whole-body NMES in combination with timed protein intake on muscle protein metabolism during bed rest are still unknown.
This study aims to investigate the impact of both a single session and repeated sessions of whole-body NMES, with or without subsequent protein intake, on muscle protein synthesis rates, muscle mass, and function during 3 days of bed rest in healthy young adults.
Study Design:
This is a randomized, placebo-controlled clinical trial with three parallel groups. Participants will be randomly assigned to one of the following groups:
- Control Group (CON): Sham-NMES + standard nutrition
- NMES Group (NMES): Whole-body NMES + standard nutrition
- NMES + Protein Group (NMES+PRO): Whole-body NMES + 20g protein bolus
Study Procedures:
Participants will be healthy adults (18-35 years, male and female) and will undergo the following procedures:
- 3 days of strict bed rest to simulate hospitalization-related muscle disuse
- Neuromuscular electrical stimulation (NMES) sessions to assess its effect on muscle metabolism
- Muscle biopsies to measure changes in muscle protein synthesis at the molecular level
- Consumption of deuterium oxide (D₂O or "heavy water") to track muscle protein turnover
- Multiple blood and saliva samples to analyze protein metabolism markers
- Leg extension tests to assess changes in muscle function
- Quadriceps muscle thickness measurements via ultrasound
- Calf circumference measurements to assess muscle mass changes
This study will provide critical insights into how NMES and protein intake can help counteract muscle loss and weakness during hospitalization and may contribute to the development of more effective rehabilitation strategies for ICU and bedridden patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a randomized, placebo-controlled intervention trial with three parallel groups. Participants will undergo 3 days of bed rest and receive either sham-NMES, whole-body NMES, or whole-body NMES with protein to assess the effects on muscle protein synthesis. The study will measure muscle protein metabolism, strength, and function to determine whether NMES and protein intake can mitigate muscle loss during immobilization.
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: Sham (No Treatment), Other: Standard nutritionSham-NMES with standard nutrition |
| Whole-body NMES group | Active comparator | Other: NMES, Other: Standard nutritionWhole-body NMES stimulation with standard nutrition |
| Whole-body NMES + protein group | Active comparator | Other: NMES, Dietary Supplement: Protein bolus (20g), Other: Standard nutritionWhole-body NMES with a 20g protein bolus on top of the standard nutrition |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged from 18-35 years
- 18.5 < BMI < 30 kg·m2
- Recreationally active (performing non-competitive physical exercise at least one time per week for minimally 30 minutes)
Key exclusion criteria (21 listed)
- Employed or undertaking a thesis or internship at the department of Human and Animal Physiology at Wageningen University
- Smoking
- Diabetes (Type 1, Type 2, or genetic form of diabetes)
- Any diagnosed cardiovascular (heart) disease or high blood pressure (≥140 mmHg systolic and/or
- ≥90 mmHg diastolic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham (No Treatment)A placebo treatment in which no actual electrical stimulation is delivered, serving as a control for the active NMES. | Other | Control group |
| NMESActive neuromuscular electrical stimulation applied to the entire body to induce muscle contractions through small electric currents. | Other | Whole-body NMES + protein group, Whole-body NMES group |
| Protein bolus (20g)A bolus dose of 20 grams of protein provided after the NMES intervention to assess the combined effect of muscle stimulation and protein intake on muscle protein metabolism. | Dietary supplement | Whole-body NMES + protein group |
| Standard nutritionProvision of a normal Western standardized diet. | Other | Control group, Whole-body NMES + protein group, Whole-body NMES group |
Primary outcome
Cumulative myofibrillar fractional synthesis rate
Time frame: Habitual MPS (Day -2 to Day 0), Acute effect of NMES (+protein bolus) (0 hours to 5 hours on Day 0), Bedrest MPS (Day 0 to Day 3),
A measure of muscle protein synthesis between two given time points.
7 secondary outcomes
Quadriceps Muscle Layer Thickness
Time frame: Between Day -21 and Day -5, Day 0, Day 3, Day 6, Week 6
Body Composition
Time frame: Day 0 and Day 3.
Body composition
Time frame: Time Frame: Day 0 and Day 3.
Quadriceps Muscle Function
Time frame: Between Day -21 and Day -5, Day 0, Day 3, Day 6, Week 6
Quadriceps Muscle Strength
Time frame: Between Day -21 and Day -5, Day 0, Day 3, Day 6, Week 6
Handgrip Strength
Time frame: Between Day -21 and Day -5, Day 0, Day 3, Day 6, Week 6
Whole-Body Nitrogen Balance
Time frame: Day 0 to Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES, Protein bolus (20g) and Standard nutrition in people with Muscle Wasting, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlou Dirks, PhD (+31 317 480 100, marlou.dirks@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative myofibrillar fractional synthesis rate (time frame: Habitual MPS (Day -2 to Day 0), Acute effect of NMES (+protein bolus) (0 hours to 5 hours on Day 0), Bedrest MPS (Day 0 to Day 3),). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.